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The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing. For these types of tests, specific "test sets" of data provenance like country of origin or retrospective/prospective often don't apply in the same way they would for clinical studies. The tests are typically performed on samples of the manufactured device. The document does not specify the exact number of samples used for each test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for these performance tests is established by standardized testing protocols and measurement methodologies, not expert consensus. These are objective measurements of material properties.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-powered device or a diagnostic device that would involve human readers. The device is a surgical mask.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

The ground truth used for these tests is based on standardized test methods and calibrated equipment. For example:

• Bacterial Filtration Efficiency (BFE): Measured using ASTM F2101, which involves generating a biological aerosol and quantifying bacterial penetration. The "ground truth" is the scientific measurement of the filtration efficiency.
• Fluid Resistance: Measured using ASTM F1862, which involves propelling synthetic blood at a known pressure. The "ground truth" is the measured penetration.
• Biocompatibility (Cytotoxicity, Sensitization, Irritation): Evaluated against recognized biological safety standards (ISO 10993) where "non-cytotoxic," "non-sensitizing," and "non-irritant" are the ground truths determined by the specific test methodologies.

8. The sample size for the training set:

Not applicable. This device is a physical medical device (surgical mask) and does not involve AI or machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

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